Guidelines for a coordinated GCP-monitoring of clinical trials published

NTA’s project on monitoring of clinical research recently released a guideline for a coordinated GCP-monitoring of clinical trials in the Nordic countries. The aim of the guidelines is to describe the prerequisites required for collaboration within the Nordic GCP Units specifically associated with the monitoring of academic trials.

In the Nordic countries GCP Units linked to hospitals and universities have a long standing tradition of working with monitoring and quality assurance regarding academic clinical trials conducted simultaneously in the Nordic countries. To strengthen the collaboration between the Nordic GCP Units Nordic Monitoring Network (NORM) was established. This guideline has been produced by NORM.

For trials conducted in more than one Nordic country the guideline will facilitate monitoring and improve the quality of the monitoring process of the specific trial.